Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

This study has been completed.
Sponsor:
Collaborator:
The University of Western Australia
Information provided by:
Papua New Guinea Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00219401
First received: September 15, 2005
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

The National Health Plan 2001-2010 calls for investigation of the feasibility of pneumococcal vaccines for Papau New Guinea. The Papua New Guinea (PNG) Institute of Medical Research, the Telethon Institute for Child Health Research and the Department of Paediatrics, University of Western Australia will collaborate to examine very closely the safety of neonatal vaccination, particularly with regard to impact on the development of immunity and response to other vaccines given to infants. This study will also provide a unique opportunity for training of PNG and Australian scientists in both countries.


Condition Intervention Phase
Pneumonia
Meningitis
Otitis Media
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Neonatal Immunization With Pneumococcal Conjugate Vaccine in Papua New Guinea

Resource links provided by NLM:


Further study details as provided by Papua New Guinea Institute of Medical Research:

Primary Outcome Measures:
  • Immunogenicity and Safety [ Time Frame: 5 yrs ] [ Designated as safety issue: Yes ]
    Serum PCV serotype-specific IgG antibody at 2, 4 and 9 mths. Mucosal PCV serotype-specific IgG antibody at 1, 3, 4 and 9 mths. PCV-induced T-cell memory (against vaccine protein carrier) at 3 and 9 mths. Local and systemic reactogenicity 48-96 hrs after vaccination. Monitoring of serious adverse events during 18 mth follow-up. T-cell development to bystander antigens at 3 and 9 mths.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Serum PCV and non-PCV serotype specific IgG antibody at 10 mths, after 23vPPV vaccination at 9 mths

  • Pneumococcal-specific acquired immunity [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Assessment of cellular immune responses to pneumococcal protein antigens at 9 and 18 months of age.


Enrollment: 318
Study Start Date: May 2005
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neonatal 7vPCV
Receive study vaccine (Prevnar) at birth, 1 and 2 months
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
Experimental: Infant 7vPCV
Receive the study vaccine (Prevnar) at 1, 2 and 3 months
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.
Placebo Comparator: Control
Do not receive study vaccine (Prevnar)
Biological: Pneumococcal 7 valent conjugate vaccine (Prevenar®)
Accelerated PCV vaccinaton.

Detailed Description:

In order to obtain the earliest possible protection against invasive pneumococcal disease, achieve optimal coverage and reduce burden of early carriage, neonatal pneumococcal conjugate vaccine (PCV) immunization needs to be considered. This study in the PNG highlands will enrol 312 infants at birth, who will be randomised to receive PCV either at 1-2-3 months (infant schedule according to PNG national EPI schedule) or 0-1-2 months of age (neonatal schedule) or receive only routine immunizations (controls). Blood samples will be taken at birth-2-3-4 months of age, pre- and post-pneumococcal polysaccharide booster (23vPPV) at 9-10 months of age (to assess immune memory) and at 18 months at study completion. Carriage will be assessed weekly for the first month of life and at regular intervals thereafter. There will be ongoing surveillance for respiratory and other diseases throughout the study. In addition to serotype-specific IgG, we will examine IgG avidity, IgG subclasses, mucosal IgA and T-cell cytokine responses to PCV and pneumococcal protein antigens. To ensure immunological safety, particularly for neonatal PCV, immune responses to concomitant vaccines and viral and environmental antigens will also be examined as well as overall T-cell maturation.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

New born babies with birth weight >2000 g (2 kgs) and parents giving consent

Exclusion Criteria:

  1. Acute neonatal infection;
  2. Severe congenital abnormality;
  3. Children of mothers known to be HIV positive will be excluded;
  4. Serious asphyxia at birth;
  5. Intended migration in the next 2 years;
  6. Parents withdraw consent;
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00219401

Locations
Papua New Guinea
Papua New Guinea Institute of Medical Research
Goroka, EHP, Papua New Guinea, 441
Sponsors and Collaborators
Papua New Guinea Institute of Medical Research
The University of Western Australia
Investigators
Principal Investigator: Peter Siba, PhD Papua New Guinea Institute of Medical Research
Principal Investigator: Deborah Lehmann, MBBS, Msc Telethon Institute for Child Health Research
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A/Prof. Deborah Lehmann, University of Western Australia
ClinicalTrials.gov Identifier: NCT00219401     History of Changes
Other Study ID Numbers: 071613/Z/03/Z, 303123 NHMRC Australia
Study First Received: September 15, 2005
Last Updated: July 10, 2011
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by Papua New Guinea Institute of Medical Research:
Pneumococcal vaccine
Antibody responses
Cellular immunology
Th1/Th2 immune responses
Paediatric
Neonatal
Infectious diseases
Papua New Guinea

Additional relevant MeSH terms:
Meningitis
Otitis
Otitis Media
Pneumonia
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 24, 2014